Gilead Sciences, Inc reports that the US Food and Drug Administration has approved Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), an once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename Sovaldi in December 2013. The FDA granted Harvoni a priority review and breakthrough therapy designation, which is given to investigational medicines that may offer major advances in treatment over available therapies.

Last month, Gilead Sciences received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency for the company's marketing authorization application for Harvoni. The CHMP opinion was adopted following an accelerated review procedure. The CHMP's recommendation will be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi. Sovaldi is also approved for use in the United States, Canada, Australia, New Zealand, Egypt, Switzerland, and Turkey. Gilead received approval from the FDA for Sovaldi in December 2013, making it the first drug approved by the FDA that demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. For the first-half of 2014, Sovaldi’s sales were $3.480 billion, or 53% of total Gilead’s first-half revenues.

Source: Gilead Sciences